- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06596421
Effect of Abdominal Massage on Constipation After Cardiac Surgery
Background and Aim: Although the incidence of gastrointestinal complications after cardiovascular surgery is reported to be rare, it has been reported that patients experience problems with constipation within the week after discharge. The presence of abdominal distension due to constipation after cardiac surgery may lead to prolonged wound healing, paralytic ileus and gastric dilatation. This study aimed to evaluate the effect of abdominal massage on constipation after cardiac surgery.
Methods: A prospective, randomised controlled quasi-experimental study was conducted in the cardiovascular surgery clinic of a public hospital between September 2022 and July 2023. A power analysis was performed to determine the sample size. A total of 130 patients were randomly assigned to the experimental or control group using a simple randomisation method. Data were collected using a 21-item form from the first day after surgery. Burping and defecation times of the patients were evaluated and recorded.
Results: The mean age of the experimental group was 55.2±13.3 years, while the mean age of the control group was 60.4±10.6 years (p=0.015). There was no statistically significant difference between the groups in terms of sociodemographic characteristics, bowel preparation and preoperative fasting times. It was observed that bowel sounds started earlier in the experimental group (70.8% on the first postoperative day) compared to the control group (46.2% on the first postoperative day) (X2=16.629; p=0.005). The first burping time measurements in the control group (x̄=46.415 hours) were higher than those in the experimental group (x̄=31.262 hours). Postoperative defecation time was longer in the control group (x̄=99.51 hours) than in the experimental group (x̄=61.611 hours).
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Bahcesehir Universty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- - Being older than 18 years
- Agreeing to participate in the study
- Undergoing a cardiac surgery
- Not having a barrier for communication
- Not having a mental or cognitive disability
- Not using constipation treatment (like laxatives or enemas)
- Having no history of constipation disorders or gastrointestinal surgery.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
no intervention
|
|
|
Experimental: experiment
abdominal massage
|
abdominal massage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient sociodemographic characteristics and physical measurements form
Time Frame: 2 days to 1 week
|
It was noted how many hours after the operation he had intestinal gas.
|
2 days to 1 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20220750
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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